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Last Updated: July 4, 2020

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KYPROLIS Drug Profile


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When do Kyprolis patents expire, and when can generic versions of Kyprolis launch?

Kyprolis is a drug marketed by Onyx Therap and is included in one NDA. There are eleven patents protecting this drug and three Paragraph IV challenges.

This drug has two hundred and nineteen patent family members in forty-one countries.

The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. Additional details are available on the carfilzomib profile page.

US ANDA Litigation and Generic Entry Outlook for Kyprolis

A generic version of KYPROLIS was approved as carfilzomib by DR REDDYS on September 9th, 2019.

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Drug patent expirations by year for KYPROLIS
Drug Prices for KYPROLIS

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Recent Clinical Trials for KYPROLIS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Janssen Research & Development, LLCPhase 2
Andrew Yee, MDPhase 2
AmgenPhase 4

See all KYPROLIS clinical trials

Paragraph IV (Patent) Challenges for KYPROLIS
Tradename Dosage Ingredient NDA Submissiondate
KYPROLIS POWDER;INTRAVENOUS carfilzomib 202714 2018-11-28
KYPROLIS POWDER;INTRAVENOUS carfilzomib 202714 2017-10-05
KYPROLIS POWDER;INTRAVENOUS carfilzomib 202714 2016-07-20

US Patents and Regulatory Information for KYPROLIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-003 Jun 7, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 AP RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for KYPROLIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1781688 93015 Luxembourg   Start Trial PRODUCT NAME: CARFILZOMIB EVENTUELLEMENT SOUS FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; FIRST REGISTRATION: 20151123
1781688 CR 2016 00014 Denmark   Start Trial PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/15/1060 20151123
1781688 122016000032 Germany   Start Trial PRODUCT NAME: CARFILZOMIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688 2016/013 Ireland   Start Trial PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688 132016000047656 Italy   Start Trial PRODUCT NAME: CARFILZOMIB OPZIONALMENTE IN FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE(KYPROLIS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1060, 20151123
1781688 PA2016010 Lithuania   Start Trial PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Moodys
Baxter
Mallinckrodt
McKinsey

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